Information Technology for the Health Care Enterprise · Information Technology Laboratory, National Institute of Standards and Technology Information Technology for the Health Care

Information Technology Laboratory, National Institute of Standards and Technology

Information Technology for the Health Care Enterprise

Ram D. Sriram, Ph.D.Chief, Software and Systems Division

URL: http://www.nist.gov/itl/ssd/[email protected]


Outline• Healthcare Vision• Health IT at NIST• Standards & Testing• Security• Biomedical Imaging• Bioinformatics• Summary

2


Healthcare Facts

• $3.5 Trillion dollars spent in 2017 on healthcare in the U.S. (http://www.cms.gov)

• It is estimated that approximately $750billion is lost due to inefficiencies in the system– Effective use of IT may help reduce these costs

• Multiple parties playing different roles

3


Information Technology Laboratory, National Institute of Standards and Technology 5


HEALTH CARE

Levels of Biological Information

Hood

BIOSCIENCES

Ecologies

Societies/Populations

Individuals

Organs

Tissues

Cells

Protein and gene networks

Protein interaction networks

Protein

mRNA

DNA

6


FutureHealthVision

Advances Making Future Health Vision Attainable

Courtesy: Jack Corley

mPCD

NetworkingCommunications

and Imaging

Advances inComputing,

Imaging, andInformationTechnology

Speed andStorage

Software (Internet,Cloud,

Data Analytics, Etc.)

Advances in HealthcareTechnology Human Genome

Project

Pharmaceuticalsand

Nutraceuticals

MedicalDevices

7

Evidence-BasedHealthcare

Continuum of Care

Advancesin

HealthcarePractice Disease

Management


The P7 Concept1. Personalized2. Predictive3. Participatory4. Precise (recommendation, decision analytics)5. Preventive6. Pervasive (including point of care)7. Protective (Privacy and security)

8Based on discussions with Leroy Hood and Ramesh Jain



9


Key Activities in Health IT• NIST enables interoperability and

adoption by:– Accelerating standards

development and harmonization

– Developing a conformance testing infrastructure

– Expanding R&D and deployment of securityprotocols

– Leveraging testing infrastructure to assist with certification process

• Leading to an emerging health IT network that is correct, complete, secure and testable.

• In addition to exploring standards and measurements for emerging technologies in health care.

Image: Shutterstock, ©Jenny Horne

10


NIST Health Care: IT Projects• Health Information Technology: Standards & Testing

• Medical Devices: Interoperability

• Biomedical Imaging

• Bioinformatics

• Text Retrieval (Past)

• Usability (Past)

• Security



12


Provide technical expertise to leverage industry-led, consensus-based standards development and harmonization as well as develop a conformance testing infrastructure to enable interoperability and adoption.

Key activities include:• Developed the conformance test method (test procedures, test data, and test tools) to

ensure compliance with the Stage 1 and Stage 2 Meaningful Use technical requirements and standards

• Under HITECH, developing a health IT standards testing infrastructure to provide a scalable, multi-partner, automated capability for current and future testing needs within the healthcare domain.

• Developing conformance test tools for fully integrated health IT systems to assure that the standards are implemented consistently.

• Collaborating with industry including Health Level Seven (HL7), IEEE, and Integrating the Healthcare Enterprise (IHE).

Standards and Testing


Health IT Interoperability

Ward

AdministrationRadiology

Laboratory

Hospital

Pharmacy

EHR

Health Info ExchangesHomecare devices

Personal Health Record

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EHRs: Key Issues

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• Input (user interfaces)

• Store (representation and persistency)

• Manipulate (search, mining, knowledge creation)

• Exchange (syntactic and semantic interoperability)

SECU

RITY


Interoperability

Electronic Health Record (EHR) System


Electronic Health Record



Laboratory Information systems (LIS)


Electronic Health Record (EHR) System Public Health



Interoperability


Medical Device Medical Device

Electronic Health Record (EHR) System Pharmacy


Electronic Health Record (EHR) System Medical Device


Semantic Mapping TechniquesThe Medical “Tower of Babel”

Vocabulary TermUMLS Metathesaurus Hypersomatotropic Gigantism

ICD-9-CM No direct translation

MeSH No direct translation

DXplain Pituitary Gigantism

Read Codes No direct translation

SNOMED Hypersomatotropic Gigantism

Some terms for “Hypersomatotropic Gigantism”:


Syntax Context Semantics Semantics Context Syntax

True EHR Interoperability

Conformance to raw message specifications in the Standard

Conformance to Specific Clinically Relevant Test data to exercise all options

Conformance to Specified Vocabularies in clinically relevant test data


• Standards are essential to achieving conformance and interoperability

• Rigorous testing is critical to achieving conformance and enabling interoperability

• Conformance CAN NOT be definitively determined* - but gives a level of confidence based on quality and quantity of test(s) performed

(*unless specification is very basic)

• Conformance Interoperability

– A is Conformant, B is Conformant• The above does not say anything about interoperability between A and B

Interoperability


Standards That Link to an EHR

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Public Health


Standards in HealthCare• Terminology

– SNOMED, LOINC• Classification Systems

– ICD9 & 10, CPT• Devices

– IEEE 11073• EHR-Related

– DICOM, HL7 (CDA)• Interoperability

– DICOM, HL7 Messaging, HIPAA Transactions, NCPDP• Language Formats

– XML, X12• Internet Protocols

– HTTP/HTTPS TCP/IP

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Information Technology Laboratory, National Institute of Standards and Technology23

Based on Oemig F, Snelick R, Healthcare Interoperability Standards Compliance Handbook. Springer International Publishing Switzerland. 2016. Page 13, Figure 1.3.

Technical InteroperabilitySignals using standard protocols for technically secure data transfer, e.g., TCP/IP

Syntactic InteroperabilityStandardized data exchange formats, e.g., HL7, XML

Semantic InteroperabilityStandardized meaning (model element) and terms / vocabulary for data interpretation,

e.g., LOINC, ICD-10CM

Organizational InteroperabilityStandardized process (workflow) elements using business process modeling tools

high

low

automatic

manualStandards

Four Levels of HIT Interoperability





• Standards can be non-existent for certain domains• Existing standards can be poorly defined• Poorly-defined standards can be poorly

implemented• Well-defined standards can be poorly implemented• Well-defined standards can be ignored (i.e., not

adopted)• Standards can compete with each other (too many

standards)

• Standards can be complex

8/9/2019 27

Use of Standards doesn’t guarantee

Interoperability

Challenges with HIT Interoperability Standards


• Under specified• Multiple solutions (occurs at all levels)• Conflation of requirements (requirement scoping)• Document current state—not desired state• Not specific enough—e.g., code system binding• Too specific• Poor documentation and typos• Lack of a consistency• Conditions w/o Condition Predicates• Absence of harmonized requirement specification methodology• Insufficient requirement specification mechanisms• Lack of reference and pilot implementations• Lack of testing• Improper scoping

8/9/2019 28

Common Issues with HIT Standards


• Health IT Standards Committee – Ram D. Sriram

Office of the National

Coordinator(ONC)

•Cross Federal Workgroup on Telehealth (FedTel) – Ram D. Sriram and John Garguilo•HITRD/NITRD – Ram D. SriramOTHERS

• Patient Care Devices (PCD) Technical Committee – Co-Chair John Garguilo• Patient Care Devices (PCD) Planning Committee – John Garguilo• IT Infrastructure (ITI) Planning Committee – Bill Majurski• IT Infrastructure (ITI) Technical Committee – Bill Majurski• Testing and Tools Committee – Bill Majurski, Robert Snelick, John Garguilo

Integrating the Healthcare

Enterprise (IHE)

• Conformance & Guidance WG – Co-Chair Robert Snelick• Healthcare Devices WG – Co-Chair John Garguilo• FHIR WG – Bill Majurski• Immunization WG – Sandra Martinez

Health Level 7(HL7)

• IEEE 11073 Medical Device Communications – John GarguiloIEEE

• Meaningful Use WG11 – Kevin BradyNCPDP

NIST Standard Activities/Working Group Participation

Government

Industry


The American Recovery and Reinvestment Act (ARRA) identifies NIST to lead the development of a health IT testing

infrastructure

• ARRA (2009) emphasizes the need to move toward electronic health records

• The legislation calls for National Institute of Standards and Technology (NIST) to contribute:– Ensure health IT standards are complete and robust– Establish a health IT standards testing infrastructure that supports

industry consensus standards development and provides robust conformance and interoperability testing capabilities

– Deploy those technologies to promote interoperable health IT adoption

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NIST And MU

• NIST developed the tests for compliance with the MU criteria.


NIST Role in ARRA MU EHR Certification Stage 1

MU Recommendations from ARRA HIT Policy and Standards Committees

CMS Final Rule – Meaningful Use Objectives and Measures

ONC Final Rule – Certification Criteria and Standards

ONC-Approved Test Method

ATCB Test ScriptsAccredited Testing and Certification Bodies**

ONC Certified Products List

Based on the requirements in the ONC Final Rule, NIST published 45 test procedures which are in use by the accredited testing laboratories to test and certify EHR products for the Meaningful Use Program

Drummond Group, Inc. Complete EHR and EHR Modules.InfoGard Laboratories, Inc. –Complete EHR and EHR Modules.ICSA Labs - Complete EHR and EHR Modules.SLI Global Solutions Complete EHR and EHR Modules.Surescripts LLC - EHR Modules: E-Prescribing, Security

** Set up by NVLAP

ATCB Testing of EHRs

Test ProceduresTest DataConformance Tools

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http://www.drummondgroup.com/

http://www.infogard.com/

http://www.icsalabs.com/

http://www.sliglobalsolutions.com/

http://www.surescripts.com/


HL7v2 Immunization Information System (IIS)Reporting Tool


Continuity of Care (CCD) C-CDA Document

NIST Tooling for Stage II and Stage III

Transport Test Tool(TTT) (includes C-CDA,

Direct, and SOAP)

HL7 CDA Cancer RegistryReporting Validation Tool

HL7v2 Syndromic SurveillanceReporting Validation Tool

HL7v2 Electronic Laboratory Reporting (ELR) Validation Tool

Electronic Prescribing(eRx)Validation Tool

Doctor’s OfficeOr Patient

Medical Devices

ePrescribingPharmacy

New Prescription(SCRIPT 10.6)

HL7 v2 IHE-PCD Validation Tool

Orders

Results

eDOS

HL7v2 Laboratory Results Interface (LRI) Validation Tool

HL7v2 Electronic Directory of Services (eDOS) Validation ToolLaboratories

HL7v2 Laboratory Orders Interface (LOI) Validation Tool

S&I Framework

Electronic Laboratory Reporting

Immunization Reporting Cancer Registry Syndromic

Surveillance


How we accomplished MU 2HL7 CDA Cancer Registry Reporting

Validation Tool

HL7v2 Immunization Information System (IIS) Reporting Validation Tool

HL7v2 Electronic Laboratory Reporting (ELR) Validation Tool

HL7v2 Laboratory Results Interface (LRI) Validation Tool

HL7v2 Syndromic Surveillance Reporting Validation Tool

Electronic Prescribing (eRx)

Transport Test Tool (TTT) (includes C-CDA, Direct, and SOAP)

Partner with CDCFour separate divisions

Partner with DIRECT Project/NwHIN

Partner with NCPDPEstablished MU WG

Partner with S&I Framework

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NIST’s Tools are foundations for MU implementations

A few $M

CMS MU

Incentive Payments

to Eligible Entities

$10’s of Billions

Development of IG Standards & Other Specifications by Work Groups (with NIST participation)

Development of Conformance Test Tools by NIST

CEHRT Configuration and Implementation at Eligible Entities’ Sites

Meaningful use of CEHRT by Eligible Entities

Meaningful Use (MU) Attestation by Eligible Entities

Improved Quality, Access, and Cost of Healthcare

EHR Certification Testing using Test Tools

CEHRT = Certified EHR Technology

Quality of the CEHRT implementations and the installed sites is directly related to the quality of the Conformance Test Tools and the underlying standards

Resolving interoperability problems is much less expensive during standards development and testing; after CEHRT deployment these problems would need to be resolved at numerous locations

28 Billion Dollars


The National Coordinator shall, in collaboration with the National Institute of Standards and Technology and other relevant agencies within the Department of Health and Human Services, for the purpose of ensuring full network-to-network exchange of health information, convene public-private and public-public partnerships to build consensus and develop or support a trusted exchange framework, including a common agreement among health information networks nationally. Such convention may occur at a frequency determined appropriate by the Secretary.

21st Century Cures Act (Dec. 2016) Sec. 4003. Interoperability


The NIST Testing Infrastructure ….…. will provide a scalable, automated environment for

current and future testing needs• NIST will collaborate with health IT stakeholders to harmonize

healthcare standards test development and delivery to ensure conformance and interoperability within the healthcare domain

• NIST will leverage existing tools and work with health IT stakeholders including:– Certification Bodies– Testing Organizations– NwHIN– Vendors– Implementers– SDOs– Other Industry Consortia

Consensus Bodies

SDOs

NHIN

HIT Vendors

System Implementers

NHIN Participants

Testing Orgs

38


Conceptual View of HIT Testing Infrastructure

Certification Body

NHIN

Other IndustryConsortia

Implementers

SDOs

Vendors

39


ImplementationGuide

Authoring &Management

Tool

The Big Picture: HL7 V2 End-to-end Testing Support

HL7 v2StandardMessageDefinition

GeneralTransactionConstraints(e.g., IG , TF,

or userinput)¹

HL7 v2Standard

Value Sets

Test CaseRequirements

VocabularyLibrary(XML)

ConformanceProfile(XML)

Test CaseManagement and Authoring

Tool

MessageProfiling

Test PlanExecution

Script(XML)

Test PlanTemplate

HL7 V2Impl.Guide

Template

Test PlanEnglish

Document

Data Sheets

Impl.GuideEnglish

Document

SpecificationValidation

ContextFile

(XML)

¹ Support existing specifications

UseCases

VocabularyProfiling

Use CaseDevelopment

DispositionTraceability

Utilities

IG TemplateWizard

ConstraintGenerator

Test CaseDevelopment

Test ScriptGeneratorData Sheet and Juror Document

Generator

Test PlanDevelopment

DocumentGenerator

Message Maker

DataManagement

MessageGeneration

TestingInfrastructure

DocumentGenerator

Execution Engine

ValidationEngine

Test Agents

Report Generation

Communication

TestingEnvironmentsCapabilities

ArtifactRepository

TestingTools

WebApplications

TestingInfrastructureComponents

Test PlanIntegration

Validation

ResourceBundle

ManagementMessageGeneration

Engine

VocabularyLibraries

(XML)

ConformanceProfiles(XML)

Test CaseSpecificContext

Files(XML)

Domain Specific

Tools

JurorDocuments

Utilities

Documentation

Communication

ResourceBundle

Test PlanExecution

Script(XML)

R. Snelick May 8th, 2012

DomainExperts

Domain Experts and Test Case Developers

User Input Tool Generated

Software Engineers

Tool Developers

ImportValue Sets

DITA XML


Medical Offices

LaboratoryPublic Health Agency

School

IIS

EMERGENCY

Hospital

Immunization InformationImmunization History/Forecasting

Immunization Information

Syndromic Surveillance Information

Immunization History/ForecastingLab Orders & Results

Reportable Labs

Cancer Case Reporting

CA Case Rpt

NIST SS Testing

ToolNIST ELR Testing

Tool

NIST C-CDA

Testing Tool

NIST IZ Testing

ToolNIST

LRI/LOI Testing Tools

NIST – National Institute of Standards and TechnologyIZ – Immunization SS – Syndromic SurveillanceELR – Electronic Laboratory ReportingLOI – Laboratory Orders InterfaceLRI – Laboratory Results InterfaceC-CDA – Consolidated Clinical Document Architecture


Medical Devices• Interoperability

• Body Area Network Standards

• Security


NISTMedical Device Communication Testing

Semantic interoperability of Medical Devices


Introduction - NeedAs hospitals deploy EMRs into their most critical care areas, the need to acquire data directly from medical devices becomes increasingly evident.

– Device data capture is “real-time”• Data is up-to-date• Decision support algorithms can run on more timely data

– Device data capture is “automatic”• Reduce nursing workload

– Device data capture is “accurate”• Automated data capture is less error prone than manual

charting

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Patient Care Health Device Connectivity

Hospital Device

Gateway(s)

Hospital Health

Records

Remote EHRs

Internal Hospital Network

Health Information Exchange

Departmental Devices and Mgmt

Systems

Acute care

Cardiology

Surgery

ER, ICU, others …

IHE DECProfiles:

PCD+RTM,PIB, SPD, ACM, PIV,

WCM, IDCO …

IHE ContentProfiles,

XDS, XDR

Note: IHE Profiles shown above were recently (March 2016) demonstrated at HIMSS16;IHE DEC PCD-01 Technical Framework “Final Text” version first became available in Q3

2011. Slide developed and provided by Paul Schluter, GE Healthcare


Personal Health Device Connectivity

Aggregation Manager

Telehealth Service Center

Health Records

Devicesaka Agents

ContinuaWAN

ContinuaHRN

ContinuaPAN

ContinuaLAN

Note: Continua 2014 Version (and subsequent updates) Guidelines available today;The Continua WAN interface uses the IHE DEC PCD-01 transaction over Web

Services. Slide developed and provided by Paul Schluter, GE Healthcare

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Problem Space Addressed through test methodsHow can we Improve Interoperability?

The NIST Approach…• Use standards to provide more economically effective solutions by

amortizing the cost of design over many implementations. • Profile standards to reduce optionality and simplify implementation and

testing.• Provide computable definitions of message syntax and semantics as well

as information models.• Use rigorous conformance (which in turn, used for certification and

conformity assessment testing).• Use other incentives to promote acceptance …


NIST, SDOs, and (Medical Device) Domain GroupsTest Ecosystem

ASTMASTM 2761

• ICE• Patient Safety• Standards development

framework

IndirectDirectNIST Tooling

Key: Relationships

CIMIT: Center for Integration of Medicine and Innovative TechnologyAAMI: Assoc. for Advancement of Medical InstrumentationTATRC: Telemedicine and Advanced Technology Research CenterMDICC: Medical Device Interoperability Coordination CouncilContinua: Continua Health AllianceOpenSDC: System & Device ConnectivityNCCoe – NIST National Cybersecurity Center of Excelence

KP: Kaiser-PermanenteWHI: West Health InstituteC4MI: Center for Medical InteroperabilityFDA: Food & Drug AdministrationMD PnP: Medical Device Plug-n-PlayICE: Integrated Clinical EnvironmentDDS: OMG Data-Distribution Service

IEEEIEEE 11073

• Nomenclature• Information Models• Standards development

framework & Conformance

IHEIHE PCD

• Pre- & Connectathon Testing• HIMSS and other venues• Rosetta → RTMMS

NISTConformance, Validation, & Interoperability Testing

• Test infrastructure• RTMMS, Nomenclature• Co-constraints• Information models• Interactions

HL7HL7 V2

• Standards Development Framework• Transactions • Value Sets• Conformance

Domain Groups

DDS

ICE

AAMIContinua

WHI

KPMD PnP

CIMITTATRC

MDICCFDA

C4MIOpenSDC

NCCoE


Work Products: Standards, Domains & NIST Test

Tools• IHE-PCD• HL7 – Health Level 7Device-to-EHR/EMR

• Pre-Connectathon• Connectathon• RTMMS - hRTM

• ISO/IEEE 11073 Medical Device Communication -Family of Standards

Device-to-DeviceModel: Manager <-> Agent

(Receives Data) (Provides data)

• RTMMS - Nomenclature• ‘DIM Modeling –

‘DIM Editor -DeviceEditor’

• ICSGenerator’ - sunsetted

• ‘ValidatePDU’ – on hold

Medical Device Domain NIST Tools


Medical Devices• Interoperability

• Body Area Network Standards

• Security



51


National Cybersecurity Center of ExcellenceHealthcare Sector

August 2019

National Institute of Standards and Technology

Information Technology Laboratory, National Institute of Standards and Technology53nccoe.nist.govNational Cybersecurity Center of Excellence

Healthcare Sector

• Projects• Securing Telehealth Remote Patient Monitoring

Ecosystem Project Description

• Securing Picture Archiving and Communication Systems Project Description

• Securing Wireless Infusion Pumps in Healthcare Delivery Organizations (SP 1800-8)

• Securing Electronic Health Records on Mobile Devices (SP 1800-1)

• Join our Community of Interest

• Email us at [email protected]

https://www.nccoe.nist.gov/projects/use-cases/health-it

https://www.nccoe.nist.gov/sites/default/files/library/project-descriptions/hit-th-project-description-final.pdf

https://www.nccoe.nist.gov/sites/default/files/library/project-descriptions/hit-pacs-project-description-final.pdf

https://www.nccoe.nist.gov/projects/use-cases/medical-devices

https://www.nccoe.nist.gov/projects/use-cases/health-it/ehr-on-mobile-devices

mailto:[email protected]


Securing Picture Archiving and Communication System (PACS)

Cybersecurity for the healthcare sector

Overview• PACS is nearly ubiquitous in

hospitals, prompting the Healthcare Sector Community of Interest (COI) to identify securing PACS as a critical need.

• This project will provide a reference architecture and an example solution for demonstrating the capabilities to address the cybersecurity challenges of a PACS ecosystem

Project StatusBuild Phase - Currently building example solution in the NCCoE lab and drafting the NIST Special Publication 1800-series Practice Guide with expected publication date of 09/2019/2019Collaborate with us• Read Securing Picture Archiving and Communication

(PACS) Project Description• Email [email protected] to join the Community of

Interest for healthcare projects

DEFINE ASSEMBLE BUILD ADVOCATEFinal Project Description

PublishedSeek Technology

Collaborators

Build Reference

Architecture and Write SP Publish draft SP and

Promote Project

https://www.nccoe.nist.gov/sites/default/files/library/project-descriptions/hit-pacs-project-description-final.pdf



Telehealth Remote Patient Monitoring (RPM)

Project Status• Define Phase –The final project

description was published in May 2019. A federal register notice seeking technology collaborators will be published soon.

Cybersecurity for the Healthcare Sector

Learn more:• Read Securing Telehealth RPM Project Description• Email [email protected] to join the Community of

Interest for healthcare projects

Project TimelineDEFINE ASSEMBLE BUILD ADVOCATE

Final Project Description

PublishedSeek Technology

Collaborators

Build Reference

Architecture and Write SP Publish draft SP and

Promote Project

Overview• Telehealth is one of the fastest

growing sectors within healthcare. It leverages network-connected devices to monitor and treat patients outside of a healthcare delivery organization’s (HDOs) closed environment. This project was driven by the NCCoE healthcare Community of Interest (COI) and will demonstrate an example solution with the capabilities to address the cybersecurity challenges of a telehealth RPM ecosystem.

https://www.nccoe.nist.gov/sites/default/files/library/project-descriptions/hit-th-project-description-draft.pdf



Outline• Background to NIST• Healthcare Vision• Health IT at NIST• Standards & Testing• Security• Biomedical Imaging• Bioinformatics• Summary: Towards Smart Health Care

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Medical Imaging• Change Analysis – Lung Cancer• NIST/QIBA Activities• Iterative Reconstruction• Interpreting Wireless Capsule Endoscopy Images• From Images to Diagnosis through Ontologies• Image Quality for Healthcare Applications• Computational Metrology for Biomedical Imaging• Performance of Scalabale Systems

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Confidence in CS Metrology & Big Data Measurements

Biological Metrology Computational Science-Experimental design-Specimen preparation

-Visual inspection -Definition of biologically meaningful objects & features

-Image correction-Stitching-Image visualization

-Segmentation & tracking & evaluation-Feature extraction & visualization

-Data-driven hypotheses-Manual labeling of samples

-Interpretation of measurements-Decisions

-Comparisons & classification & cross-validation-Confidence in models due to data variations and computational parameters

MACHINE LEARNING

INTERACTIVITY

SW & HW IMPEDANCE


Use Case: Age–Related Macular Degeneration (AMD)

• 11 million affected people in the US. Leading cause of vision loss in adults.

• Estimates of the global cost is $343 billion, including $255 billion in direct health care costs.

• Stem cell engineering of retinal pigment epithelium to treat macular degeneration (collaboration with NIH)

20/20 Vision

AMD vision

Stem Cell Therapy

+Images

Quality Measurements

http://en.wikipedia.org/wiki/File:Human_eyesight_two_children_and_ball_with_age-related_macular_degeneration.jpg


Use Case: Age–Related Macular Degeneration (AMD)

20/20 Vision

AMD blurred vision

Scale• Single Microscope

FOV (10X) = 0.034% of 10 cm diameter dish ~1 MB <1 TB image of total

dish over time

Complexity• Phase Contrast• Fluorescent imaging• Bright-field imaging

Imaging instruments

Speed• Identify & count

healthy cells/colonies

• Distribution of cells

SINGLE FOVSAMPLE

Therapy Failed

Therapy Worked

http://en.wikipedia.org/wiki/File:Human_eyesight_two_children_and_ball_with_age-related_macular_degeneration.jpg


Outline• Healthcare Vision• Health IT at NIST• Standards & Testing• Security• Biomedical Imaging• Bioinformatics• Summary: Towards Smart Health Care

61


Bioinformatics: Projects• Cellular Markers that Report

Microenvironment• Dynamic Measurements in Live Cells• Computational Geometry• Protein-Protein Interaction Networks• Precision Medicine• Performance of Scalabale Systems

62


Motivation• Cyclin-dependent kinase 5 (Cdk5)

operates in human brain– Involved in cell development, cancer

and neurodegeneration• P25 is a pathological cdk5 activator

– Cdk5/p25 causes phosphorylation of brain protein tau (Alzheimer’s disease)

• An experimental study of the effects of truncated fragments of p25 on Cdk5 activity is carried out in the Neurochemistry Lab, NINDS

• Inhibitory fragments inhibit cdk5/p25 pathology, but inhibition mechanisms are unknown

• Small fragments are needed for effective clinical trials– No side effects, can cross blood

brain barrier

cdk5/p25 complex

Amino acids in red are removed from p25 to obtain CIP

Cdk5 activity .vs. inhibitor concentration

[Ami02] 63


Problem Formulation• Fragments are randomly obtained from p25 and tested (years

of work)– First inhibitor tested, CIP, consisted of 124 amino acids (too big!)– Smaller inhibitor tested so far, p5, consists of 24 AAs

• Can cross the blood brain barrier• It is still big, so high probability of side effects

• Computer-based studies should be used to provide insights into Cdk5-inhibitor bindings– Binding prediction and simulation

• No more random truncations of p25 fragments, but computer-aided peptide design

p5CIP


Proposed approach• A method to predict protein-protein association in solution has been

defined [1,2]• Basic idea: in the early stages of complexation, proteins form metastable

preferential first-encounter complexes, from which stable binding modes evolve. The main steps are:

1. Protein conformers are obtained using a Monte Carlo (MC) method

2. For each pair of conformers, MC optimizations yield a set of first-encounter modes, defining a probability distribution

3. First-encounter modes are combined into a generalized probability function to simulate protein-protein systems using self-adaptive configurational bias-MC simulations.

4. The binding modes thus obtained are refined using Molecular Dynamics (MD) simulations


Results• Cdk5-p5 pharmacophore was characterized

– Strong electrostatic interactions identified

– Spatial arrangement and critical AAs known

– Dynamic stability tested

66

p5Cdk5


Outline• Background to NIST• Healthcare Vision• Health IT at NIST• Standards & Testing• Biomedical Imaging• Bioinformatics• Summary: Towards Smart Health Care

67


HEALTH PERSONA

Logical Sensor Physiological SensorsFitness Tracking Sensors

Life Event

Kinetic Event

Physiological Event

Food Event

Personicle

Defining Health Persona

CalendarAc

tivity

-leve

l

Hear

trat

e

Home Drive Meeting Work ExerciseWal

k

Wal

k

Courtesy: Ramesh Jain, UCI68


Personal Health Record

69


GenomicAnalysis

HEALTH PERSONA+ PHR

CYP2C19

Plavix?


EventShop : Global Situation Detection

Predictive Situation

Recognition

Evolving Global Situation

Predictive Personal Situation

Recognition

Personal EventShop

Evolving Personal Situation

Need- Resource Matcher

Recommendation Engine

PersonaDatabase

Resources

Needs

Data Ingestion

Wearable Sensors

Calendar

Location

….

Dat

a So

urce

sData

Ingestion and

aggregationDatabase Systems

Satellite

Environmental Sensor Devices

Social Network

Internet of Things

Actionable Information

Courtesy: Ramesh Jain, UCI

70

- Example of Physical Data- AQI: 250 (Air Quality Index

0<AQI<500) at Location DC

- GPS: 38, 53, 77, 02, 12:00 - Temperature: 60 F

- Location identification DC / Map Visualization at time 2:30 pm

Example of Rules- R1: If (301<AQI<500 at Location DC ) Then (“Health alert”:

everyone may experience more serious health effects) http://www.airnow.gov/

- R2: If (Disease = “Asthma” and AQI>200) Then (message…)- …

- Event: Breathing/cough symptom- Posted by: a patient- Where: DC- When: 2/21/13 ç2:30 am

Prone to Asthmatic reactionsIs in outside location DC at time 2:30 pmHigh Probability of attack

Air quality not suitable for your Asthma – Move-Indoors

http://www.airnow.gov/

Courtesy: Fred Hosea, Ph.D.Program DirectorClinical Technology

[email protected]

27Periodic

CartREADINESS

CHECK (W/LANaccess reqd)

42

1Users aretrained on

service modeland contact #

4SSS

opens RemedyIncident record

16BMET

ONSITEASSESSMENT

24HOT SWAP

POOLPrep, Config,

Charge, Store,Repair,

Warranty,Restore

13BMET

closes anyREMAINING

task(s)

11IT

Close INCIDENTRECORD

12IT may escalate,involve Vendor,orrefer to Biomed for

further action

10IT

Resolves?

8

28InvolveVendor

as needed

21Activate & verify

Cart performance.

2VRU pick on

IT Helpdesk #or HD forwards

call to SSS

Some users may call KPITHelpDesk with cart

problems

IT Depot

Biomed Shop

Sept 11, 2006

17FIX orSWAPunit ?

20Retrieve Hot Swap

Cart from closet

26HotSwap

Restore to Closetcompleted.

Close CARTRESTORE task

19CART Assemblyfunction restored.

Close CARTREPAIR task/

record.

Shop/Depotrelationship &procedures willprobably varyfrom facility tofacility,depending onlocal setups,distances, andschedules, butwill bestandardizedover time.

Biomed Shop:Maintain stock of CART partsHave 1 spare laptop?

“Down” unit becomesnew hot swap

3Note: This is a generic model for service management. Actual elements andsequences may vary between service areas and regions.

22Configure laptopfor location, for

printing.Close CARTSWAP task

25Repair failed

laptopReturn fixed laptopto Hot Swap pool

Update Assetrecords

23Restore

HOT SWAPreadiness within

(24?) hrs.

18Fix cart

COMPONENTproblem

BatteryBarcode readerElevation motorWheelsKeyboardMouseMonitorInfection control?

Carts should have aservice tag withcontact info

Eventual goal: track both Biomed and Remedy ref. #s in both systems

Remedy record may consist of several subtasks and is not consideredclosed until Hot Swap readiness is restore.dNumbering of steps is for reference purposes and does notnecessarily indicate temporal sequence or relationship.

5InitialTriage

6Resolution

ByQuick Fixes or

Appication consult

14Dispatch

BIOMED to site

9Handoff to

IT

7Close RemedyIncident Record

15

IT Triage

LaptopProblem?

SWProblem?

Network,WirelessProblem?

Optional phone consultBiomed / IT Peer or Help Desk

As needed

Fix

SWAP

8Assign

Overview of Production Support Model for HC Wireless Cart - rev. 12

BIOMED VENDORIT/BiomedCoord

KEY

IT

15

Site SupptSpecialist

3User calls SSS

(Site Support Spec)and describes

problem

Smart Healthcare• Smart Devices• Smart Networks• Smart Processes• Smart EMRs• Smart Medicine• Smart Organizations• Smart Collaborations• Smart Society• Smart Planet


Smart Doctor

72Courtesy: Rod Grupen & Tihomir Latinovic


Summary

We develop measurements, tools, and prototypes, and contribute to voluntary standards to advance the use of information technologies in healthcare systems and achieve an interconnected electronic health information infrastructure.– Collaborate with industry to develop clear, testable public specifications– Based on industry priority we develop conformance test suites to ensure

correct, robust interoperable software– Develop prototypes of emerging HC standards to fill in the gaps that are

identified by industry– Develop the Health IT Testing Infrastructure– Research into standards, measurements, and testing methodologies for

emerging technologies

73


Acknowledgments• Testing (EHR & Medical Devices): Kevin Brady, John

Garguilo (medical devices), Michael Indovina, William Majurski, Sandra Martinez, Andrew McCaffrey, Robert Snelick, Sheryl Taylor, Kevin Stine and NCCOE, and several contractors

• Biomedical Imaging & Bioinformatics: Mary Brady (PI), Peter Bajcsy, Paul Boynton [telehealth], Joe Chalfoun(GR), Antonio Cardone (GR), Marcin Kociolek (GR), Adele Peskin, Piotr M. Szczypinski (GR), Walid Keirouz, and other others

• Smart Health Care: E. Subrahamanian (IPA)• Collaborators: MML, NIH, UMCP, UMBC, UCI, Etc.

74


Disclaimer

• Commercial equipment and software, many of which are either registered or trademarked, are identified in order to adequately specify certain procedures. In no case does such identification imply recommendation or endorsement by the National Institute of Standards and Technology, nor does it imply that the materials or equipment identified are necessarily the best available for the purpose.

75